Comparative Analysis: EMA’s PRIME Scheme vs. MHRA’s ILAP
Navigating Accelerated Pathways for Innovative Medicines in the EU and UK
The European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) scheme and the Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP) represent flagship initiatives to expedite the development and market access of breakthrough therapies addressing unmet medical needs.
Launched in 2016 and 2021 respectively, these voluntary programs emerged from a shared vision: to bridge regulatory gaps, foster innovation, and deliver life-changing treatments faster amid rising demands for therapies in oncology, rare diseases, and advanced modalities like gene and cell therapies. PRIME, refined through a 2023 five-year review, emphasizes early EMA dialogue to optimize data generation and enable accelerated assessments.
ILAP, relaunched in March 2025 with streamlined entry criteria and deeper NHS integration, positions the UK as a post-Brexit hub for “end-to-end” access, from early development to NHS adoption.
This article compares the two schemes across key dimensions, drawing on official guidance and recent updates (as of October 2025).
Both schemes align with global standards (e.g., FDA’s Breakthrough Therapy Designation), but divergence in scope, timelines, and integration reflect the EU’s collaborative network versus the UK’s agile, national system.
Background and Objectives
PRIME was introduced by EMA in response to the European Commission’s STAMP expert group recommendations, aiming to reinforce early dialogue for medicines with major public health impact. It targets unmet needs where existing treatments fall short, promoting robust evidence generation to support expedited marketing authorizations (MAAs). Updates in 2023 (post-five-year review) introduced roadmaps, product trackers, and enhanced support for small/medium enterprises (SMEs) and academia, with oncology comprising 27% of applications.
ILAP, launched amid Brexit’s regulatory independence, evolved from MHRA’s ambition to outpace EU timelines. The 2025 relaunch addressed prior feedback on unsustainable entry (overly permissive criteria led to 166 passports by 2024) by tightening focus on “transformative” products—those offering step-changes in care for NHS priorities like rare diseases or oncology. Objectives include slashing time-to-patient by 3–6 months through parallel regulatory/HTA processes, with new emphasis on drug-device combinations and early clinical-stage entry.
Both schemes prioritize patient-centric innovation but differ in maturity: PRIME has matured into a data-rich program (536 applications by April 2025, 26% eligibility rate), while ILAP’s relaunch signals a leaner, more selective model (first window: March–July 2025).
Eligibility Criteria
Eligibility for both hinges on unmet need and therapeutic innovation, but PRIME requires more advanced evidence, while ILAP allows earlier entry.
- PRIME: Targets medicines with preliminary data (e.g., Phase 1/2) demonstrating major advantages over existing options or for untreatable conditions. Key criteria: Significant impact on disease progression/survival; innovative mechanisms (e.g., ATMPs, CAR-T); no current therapies or major gaps. SMEs/academia favored (54% of applicants). Out-of-scope: Routine improvements or non-novel products. As of September 2025, 24% of 350+ requests granted eligibility.
- ILAP: Broader and earlier—now from pivotal nonclinical data or early clinical (post-2025 relaunch). Focuses on “transformative” potential for NHS unmet needs (e.g., life-threatening conditions, health inequalities). Includes drug-device combos. Selective criteria: Evidence of step-change efficacy/safety; alignment with UK priorities. Non-commercial developers eligible; global applicants welcome. Innovation Passport (first step) reviewed by MHRA/NICE/SMC/AWTTC.
PRIME’s bar may be higher (26.5% oncology success rate), suiting EU-scale trials; ILAP’s flexibility aids UK pilots or adaptive designs.
Key Features and Benefits
Both provide enhanced interactions, but ILAP’s multi-stakeholder model extends beyond regulation to reimbursement.
| Feature | EMA PRIME | MHRA ILAP |
| Entry Mechanism | Eligibility request via EMA portal; rapporteur from CHMP/CAT assigned. | Innovation Passport application via portal; TDP (Target Development Profile) co-developed with partners. |
| Support Tools | Early scientific advice (free for SMEs); protocol assistance; accelerated assessment eligibility (150-day MAA review); PRIME roadmap/tracker (2023 update). | Joint scientific advice (MHRA/NICE); prioritized scheduling (e.g., pre-submission meetings); access to CPRD data/NIHR trials; ILAP Access Forum for NHS uptake; rolling reviews. |
| Timeline Acceleration | Optimizes trials for robust data; potential 60-day accelerated assessment. | End-to-end: 3–6 months faster NHS access; parallel MHRA/HTA decisions (no 90-day lag). |
| Patient/HTA Integration | Optional EUnetHTA parallel advice; patient input via scientific committees. | Built-in NHS involvement; NICE/SMC for HTA alignment from early stages. |
| Scope | Novel medicines/ATMPs for EU centralized procedure; rare diseases prioritized. | Transformative medicines/combos; NHS-focused (e.g., health inequalities). |
PRIME’s strengths lie in EMA’s expertise for complex trials (e.g., 16 rare disease designations in 2023); ILAP shines in practical UK rollout, with 2025 additions like Active National Delivery for trial infrastructure.
Application Process and Timelines
- PRIME: Submit anytime via EMA’s IRIS portal with scientific summary and unmet need rationale. Review: 60–90 days; annual updates required. Post-eligibility: Kick-off meeting, then tailored advice. Full MAA eligibility for accelerated path at filing.
- ILAP: Windows-based (e.g., March–July 2025); apply for Passport via MHRA portal with TDP form. Review: 30–60 days; TDP meeting follows. Ongoing: Quarterly forums, prioritized advice. Relaunch emphasizes single-point contacts to avoid duplicates.
PRIME suits ongoing EU programs; ILAP’s structured windows favor phased UK strategies.
Implications for Sponsors and Industry
For multinational sponsors, PRIME unlocks EU-wide access (27 Member States), ideal for scale-up, but its 26% eligibility demands strong early data—oncology applicants face stiff competition.
ILAP, with ~40% Passport grants historically, appeals to UK-prioritizing firms (e.g., post-Brexit biotechs), offering reimbursement certainty via NICE integration, potentially boosting ROI by 20–30% through faster uptake. Both reduce development risks: PRIME via data optimization (e.g., 10 conditional MAs since 2016); ILAP via NHS pilots.
Challenges persist – PRIME’s high threshold excludes incremental innovations; ILAP’s selectivity (post-2025) may limit volume. Post-Brexit divergence means dual applications for EU/UK coverage, though alignments (e.g., PRIME’s 2023 roadmaps mirroring ILAP’s TDP) ease burdens. SMEs benefit most: PRIME waives fees; ILAP provides non-commercial support.
Conclusion:
Complementary Paths in a Fragmented Landscape
EMA’s PRIME and MHRA’s ILAP are not rivals but complements. As of October 2025, PRIME’s 84 designations underscore its maturity, while ILAP’s relaunch (160+ prior passports) signals renewed ambition. Sponsors should assess pipelines against NHS/EU priorities: PRIME for pan-European ambition, ILAP for swift UK launches. With ongoing refinements (e.g., EMA’s 2025 eligibility recommendations; MHRA’s Q4 webinars), these schemes fortify the transatlantic innovation corridor. For full details, consult EMA’s PRIME page and MHRA’s ILAP guidance. This analysis reflects positions as of October 17, 2025; monitor updates via official channels. Sponsors eyeing applications? Early consultations can align strategies across borders.
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